Comprehensive Modular Hybrid Glenoid SSI001911

GUDID 00880304992795

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00880304992795
• NIH Device Record Key: 045ae1fe-f5b0-4b7b-b156-c838fa4d6a1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive Modular Hybrid Glenoid
• Version Model Number: SSI001911
• Catalog Number: SSI001911
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304992795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304992795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-06-19

On-Brand Devices [Comprehensive Modular Hybrid Glenoid]

• 00880304993310: SSI002232
• 00880304993297: SSI002230
• 00880304993037: SSI002231
• 00880304992818: SSI000916
• 00880304992801: SSI001912
• 00880304992795: SSI001911
• 00880304992788: SSI001962
• 00880304992771: SSI001961
• 00880304992764: SSI001960
• 00880304848337: SSI003626